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Home › Online Training ›  QA/QC

Quality Assurance and Quality Controls Training - Live Webinars, Recordings & CDs

Whether you are a quality assurance or a quality control professional, you know how the rapid transformations in regulatory requirements and technology are changing the nature of your work. We understand this challenge and have put together quality assurance and quality control courses to help you make your role robust-proof. Browse for the many courses, standards, and tools of specific interest to you.
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Recorded/CD
The Use of Monitoring and Statistics to Prevent Non-Compliance in the Laboratory

The Use of Monitoring and Statistics to Prevent Non-Compliance in the Laboratory

  • Speaker: John Fetzer
  • Product ID: 705292
  • Duration: 60 Min
This webinar will cover the basic statistics of compliance and non-compliance and how to use a statistical approach to monitor the operation in the laboratory.
CD/Recorded
$169
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Recorded/CD
Understanding and Implementing a Technology Transfer Process

Understanding and Implementing a Technology Transfer Process

  • Speaker: Steven Laurenz
  • Product ID: 705031
  • Duration: 60 Min
This webinar will discuss the steps to guide the technology transfer for the successful implementation, ensures that products of the highest quality are delivered to the patients along with meeting the business demands of the company.
CD/Recorded
$169
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Recorded/CD
Objectionable Microorganisms in Biopharmaceutical Manufacturing

Objectionable Microorganisms in Biopharmaceutical Manufacturing

  • Speaker: Carl Patterson
  • Product ID: 705319
  • Duration: 60 Min
This webinar will discuss the regulations pertaining to objectionable microorganisms, agency expectations, methods to identify objectionable microorganisms, interpreting results, and controls to put into place.
CD/Recorded
$169
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Recorded/CD
Validation of GC / GC-MS Methodologies

Validation of GC / GC-MS Methodologies

  • Speaker: John Fetzer
  • Product ID: 705259
  • Duration: 60 Min
This training program will cover in detail the method validation of gas chromatography (GC) and gas chromatography mass spectrometry (GC-MS). It will focus on key elements of validation including injector, column, detection system, data system and much more.
CD/Recorded
$169
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Recorded/CD
Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes

Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes

  • Speaker: Charity Ogunsanya
  • Product ID: 703885
  • Duration: 90 Min
This training program will highlight mistakes often made when corrective and preventative actions are not clearly identified and applied during a manufactured product sterility test failure investigation because an ineffective investigational procedure and tool was used to conduct a sterility test failure investigation. The webinar will also illustrate how avoiding such common mistakes will ensure that these types of products meet the sterility requirements USP <71> and other regulatory guidelines applicable to finished products, bulk drug substance, raw materials or excipients.
CD/Recorded
$189
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Recorded/CD
Analytical Method Validation Under Good Laboratory Practices (GLPs)

Analytical Method Validation Under Good Laboratory Practices (GLPs)

  • Speaker: John Fetzer
  • Product ID: 703561
  • Duration: 60 Min
This laboratory compliance training will teach you how to validate an analytical method under the GLP requirements. It will cover in detail the criteria for the validation of an analytical method including statistical and documentation requirements.
CD/Recorded
$0
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Recorded/CD
Understanding the FDA Compounding Pharmacies Guidance

Understanding the FDA Compounding Pharmacies Guidance

  • Speaker: Carl Patterson
  • Product ID: 705348
  • Duration: 60 Min
This webinar will cover in detail the FDA Compounding Pharmacies Guidance and will review the Aseptic Guidance document. It will help Compounding Pharmacies understand what actions are needed in order to prevent insanitary conditions.
CD/Recorded
$169
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Recorded/CD
Understanding and Implementing a Quality by Design (QbD) Program

Understanding and Implementing a Quality by Design (QbD) Program

  • Speaker: Steven Laurenz
  • Product ID: 705001
  • Duration: 60 Min
This webinar will help you understand Quality by Design (QbD) principles used in pharmaceutical product manufacturing, outline the key steps to implement a QbD program and discuss the tools used to implement a QbD approach.
CD/Recorded
$159
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Recorded/CD
Automating Assays for Clinical Diagnostics

Automating Assays for Clinical Diagnostics

  • Speaker: Todd Graham
  • Product ID: 703268
  • Duration: 60 Min
This webinar on automating laboratory assays will teach you how to translate an assay that is performed manually to one that is fully automated, with high quality and with proper validation and quality assurance for regulatory purposes.
CD/Recorded
$0
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Recorded/CD
Laboratory Accreditation (ISO/IEC 17025): Everything Old is New Again

Laboratory Accreditation (ISO/IEC 17025): Everything Old is New Again

  • Speaker: Michael Brodsky
  • Product ID: 705272
  • Duration: 60 Min
This training program will discuss in details the new requirements of ISO/IEC 17015:2017 laboratory accreditation standard and their impact on quality management system. It will provide you with an overview of the salient differences and similarities between the old and the new standard and provide advice on what you must do to meet the requirements each of the elements.
CD/Recorded
$169
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Recorded/CD
Where FDA Is Heading in Regulating Laboratory-Developed Tests

Where FDA Is Heading in Regulating Laboratory-Developed Tests

  • Speaker: Dennis Weissman
  • Product ID: 705335
  • Duration: 60 Min
The webinar will cover the federal regulatory approach to regulating laboratory-developed tests including the role of CLIA, the rationale for and opposition to direct FDA oversight, the goal of possible federal legislation and the prospects for future action by the FDA and/or Congress.
CD/Recorded
$199
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Recorded/CD
Fishbone Diagramming

Fishbone Diagramming

  • Speaker: Michael Abitz
  • Product ID: 705338
  • Duration: 90 Min
This webinar will teach you how to identify potential process problems and avoid process interactions through effective process mapping. It will cover steps to create a fishbone diagram including its purpose, advantages and how to present it.
CD/Recorded
$179
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Recorded/CD
SOP's for Bioanalytical Methods Validation

SOP's for Bioanalytical Methods Validation

  • Speaker: Todd Graham
  • Product ID: 704916
  • Duration: 60 Min
This webinar will help you learn how to validate bioanalytical methods. This session will teach you the pitfalls behind bioanalytical methods validation, allowing one to transition between assays with ease.
CD/Recorded
$0
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Recorded/CD
OTC Drug Regulations

OTC Drug Regulations

  • Speaker: Loren Gelber
  • Product ID: 705446
  • Duration: 60 Min
This webinar will provide attendees with the knowledge and skills needed to develop and produce an OTC drug product for marketing and sale in the U.S.
CD/Recorded
$179
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Recorded/CD
Quality Risk Management Overview for Pharma, Biopharma and Combination Products - ICH Q9/ISO 14971

Quality Risk Management Overview for Pharma, Biopharma and Combination Products - ICH Q9/ISO 14971

  • Speaker: Tanvir Mahmud
  • Product ID: 702422
  • Duration: 90 Min
This 90-minute webinar will cover principles and provide examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. It will provide you with the knowledge and understanding needed to improve patient safety and also to prepare your organization for regulatory inspections.
CD/Recorded
$189
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Recorded/CD
CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE

CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE

  • Speaker: Sunil Gupta
  • Product ID: 704316
  • Duration: 90 Min
This training session is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. The program will provide effective and practical solutions to address real-world issues.
CD/Recorded
$159
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Recorded/CD
Risk Management of Source Water used in the Food Industry

Risk Management of Source Water used in the Food Industry

  • Speaker: Michael Brodsky
  • Product ID: 703211
  • Duration: 60 Min
This training on source water protection will address the issue of source water protection and the potential impact on the food industry. Attendees will learn the best practices for the protection of source water and risk management from a microbiological perspective.
CD/Recorded
$0
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Recorded/CD
Failure Mode Effects Analysis

Failure Mode Effects Analysis

  • Speaker: Michael Abitz
  • Product ID: 705333
  • Duration: 60 Min
This webinar will explain how to create Failure Mode Effects Analysis (FMEA) by combining Effective Information Collection (EIC), Process Reliability Modeling (PRM) and Failure Mode Effect Criticality Analysis (FMECA). It will also cover the methods for determining root causes of process problems and effective tools for repair of ineffective processes.
CD/Recorded
$189
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Recorded/CD
CDISC Mapping 4: SDTMs and ADAMs Examples (80%/20% Mapping Rule)

CDISC Mapping 4: SDTMs and ADAMs Examples (80%/20% Mapping Rule)

  • Speaker: Sunil Gupta
  • Product ID: 704313
  • Duration: 90 Min
This training program is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Through case study analysis, the course will examine best practices to provide thoughts and ideas to develop or improve the CDISC mapping system.
CD/Recorded
$299
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Recorded/CD
Process Reliability Modeling: Measure the Cause Not the Effect of Process Variations

Process Reliability Modeling: Measure the Cause Not the Effect of Process Variations

  • Speaker: Michael Abitz
  • Product ID: 705334
  • Duration: 60 Min
This webinar will discuss in detail Process Reliability Modeling (PRM) method including its history, the process, validation, and results of effective management, sigma score and customer satisfaction. Attendees will learn how to convert qualitative information into quantitative data to determine process and system reliability.
CD/Recorded
$179
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